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Second Open Label Extension to Bridging Study CTBM100C2303

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01069705
First received: February 15, 2010
Last updated: May 2, 2012
Last verified: May 2012
History of Changes
  Purpose

This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.


Condition Intervention Phase
Pulmonary Infections
Pseudomonas Aeruginosa
 Drug: Tobramycin inhalation powder
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1.

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis. [ Time Frame: Each visit during the 168-day treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile. [ Time Frame: Each visit during the 168-day treatment period ] [ Designated as safety issue: No ]
  • Density of microorganisms in sputum samples [ Time Frame: Each visit during the 168-day treatment period ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TIPnew Drug: Tobramycin inhalation powder
Tobramycin inhaled powder

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study
  • Confirmed diagnosis of cystic fibrosis patients with P. aeruginosa infection.
  • FEV1 at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

  • Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.
  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069705

Locations
Bulgaria
Novartis Investigative Site
Pleven, Bulgaria
Novartis Investigative Site
Polvdiv, Bulgaria
Novartis Investigative Site
Sofia, Bulgaria
Novartis Investigative Site
Varna, Bulgaria
Estonia
Novartis Investigative Site
Tallin, Estonia
Novartis Investigative Site
Tartu, Estonia
Latvia
Novartis Investigative Site
Riga, Latvia
Lithuania
Novartis Investigative Site
Kaunas, Lithuania
Novartis Investigative Site
Vilnius, Lithuania
Romania
Novartis Investigative Site
Bucharest, Romania
Novartis Investigative Site
Timisoara, Romania
Russian Federation
Novartis Investigative Site
Kazan, Russian Federation
Novartis Investigative Site
Moscow, Russian Federation
Novartis Investigative Site
Saint Petersburg, Russian Federation
Novartis Investigative Site
Samara, Russian Federation
Novartis Investigative Site
Yaroslavl, Russian Federation
South Africa
Novartis Investigative Site
Durban, South Africa
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01069705     History of Changes
Other Study ID Numbers: CTBM100C2303E2
Study First Received: February 15, 2010
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration
Bulgaria: Ministry of Public Health
Estonia: The State Agency of Medicine
European Union: European Medicines Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Romania: Ministry of Public Health
Russia: Ministry of Health of the Russian Federation
South Africa: Department of Health

Keywords provided by Novartis:
Tobramycin Inhalation Powder
Cystic fibrosis
Lung diseases
Anti-Bacterial Agents
Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis patients

Additional relevant MeSH terms:
Cystic Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
 Gram-Negative Bacterial Infections
Bacterial Infections
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013